TuBaFrost 3: Regulatory and ethical issues on the exchange of residual tissue for research across Europe

E. B. van Veen, P. H J Riegman, W. N M Dinjens, K. H. Lam, M. H A Oomen, A. Spatz, R. Mager, C. Ratcliffe, K. Knox, D. Kerr, B. van Damme, M. van de Vijver, H. van Boven, M. M. Morente, S. Alonso, D. Kerjaschki, J. Pammer, J. A. Lopez-Guerrero, A. Llombart Bosch, A. CarboneA. Gloghini, I. Teodorovic, M. Isabelle, A. Passioukov, S. Lejeune, P. Therasse, J. W. Oosterhuis

Research output: Contribution to journalArticlepeer-review

Abstract

The regulatory regimes for research with residual tissue and accompanying data differ widely between countries in the European Union (EU): from specific consent to opt-out or even no consent at all. This could greatly hamper research where the exchange of tissue and accompanying data has become the gold standard, like in TubaFrost. Instead of adhering to international guidelines, which have a democratic deficit, or an attempt for a new set of possible harmonising rules, TubaFrost chose to create a coordinating rule: if tissue may legitimately be used for a certain kind of research in the country where it was taken and under whose jurisdiction the patient falls, it may also be used for such research in the country where it is sent to in the context of a scientific program even if in that other country other regulations would apply for research with residual tissue taken from patients under their jurisdiction. This coordinating rule has a sound basis in EU law in general and will solve the problems related to diverging national regulatory regimes in the case of cross national research with residual tissue.

Original languageEnglish
Pages (from-to)2914-2923
Number of pages10
JournalEuropean Journal of Cancer
Volume42
Issue number17
DOIs
Publication statusPublished - Nov 2006

Keywords

  • Biobanking
  • Code of conduct
  • Consent
  • European regulations
  • Exchange of residual tissue

ASJC Scopus subject areas

  • Cancer Research
  • Hematology
  • Oncology

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